Clinical trial · Interventional
Multicentric Randomised Trial for Resectable Gastric Cancer
A Multicentre Randomised Phase II Trial of Neo-adjuvant Chemotherapy Followed by Surgery vs. Neo-adjuvant Chemotherapy and Subsequent Chemoradiotherapy Followed by Surgery vs. Neo-adjuvant Chemoradiotherapy Followed by Surgery in Resectable Gastric Cancer
NCT02931890CI-TRIAL-00076665CRITICS-IIactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts: * Preoperative treatment is associated with better patient compliance than postoperative regimens * Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections * Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| gastrectomy | Procedure | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| radiotherapy of gastric cancer | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- neo-adjuvant chemotherapy followed by surgery
- description
- 4 courses of 3 weekly DOC followed by surgery
- interventionNames
- Drug: Docetaxel
- Drug: Oxaliplatin
- Drug: Capecitabine
- Procedure: gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- neo-adjuvant chemo and subsequent CRT followed by surgery
- description
- 2 courses of 3 weekly DOC and subsequent CRT followed by surgery
- interventionNames
- Drug: Docetaxel
- Drug: Oxaliplatin
- Drug: Capecitabine
- Procedure: gastrectomy
- Radiation: radiotherapy of gastric cancer
- Drug: Paclitaxel
- Drug: Carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction * WHO \< 2 * Age ≥ 18 yrs * Resectable adenocarcinoma of the stomach or gastro-oesophageal junction * No prior abdominal radiotherapy * Haematology: Hb ≥5.0 mmol/l; leukocytes≥3.0x109/l, neutrophils ≥1.5x109/l, thrombocytes ≥100x109/l * Renal function: serum creatinine ≤1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula) Liver function: total bilirubin ≤1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN * At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial free peritoneal fluid if any should be pathologically proven tumor negative * Written informed consent * Expected adequacy of follow-up * Caloric intake≥1500 kcal/day, verified by a dietician before registration. * if caloric intake is \< 1500 kcal/day or if bodyweight has decreased \> 10% over the last 6 months or \> 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory Exclusion Criteria: * T1N0 disease (assessed by endoscopic ultrasound) * Distant metastases * Inoperable patients; due to technical surgery-related factors or general condition * Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri; in case of a previous other malignancy with a disease-free period≥5 years, inclusion can be accepted after consultation of the principal investigator * Solitary functioning kidney that will be within the radiation field * Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery * Uncontrolled (bacterial) infections * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias * Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednison * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine * Neurotoxicity \> CTC grade 1 * Pregnancy or breast feeding * Patients (M/F) with reproductive potential not implementing adequate contraceptive measures * Gastric or gastro-esophageal stent within radiation field
References
Publications (2)
- DERIVEDKlute KA, Shah MA. Evolving Therapeutics for Resectable Esophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257044. doi: 10.6004/jnccn.2025.7044. PMID 40340830
- DERIVEDSlagter AE, Jansen EPM, van Laarhoven HWM, van Sandick JW, van Grieken NCT, Sikorska K, Cats A, Muller-Timmermans P, Hulshof MCCM, Boot H, Los M, Beerepoot LV, Peters FPJ, Hospers GAP, van Etten B, Hartgrink HH, van Berge Henegouwen MI, Nieuwenhuijzen GAP, van Hillegersberg R, van der Peet DL, Grabsch HI, Verheij M. CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer. BMC Cancer. 2018 Sep 10;18(1):877. doi: 10.1186/s12885-018-4770-2. PMID 30200910